BACKGROUND: Since 1996, several forms of nicotine replacement therapies (NRTs) have switched from prescription to over-the-counter (OTC) status, allowing the public to wean off nicotine dependence without physician supervision. While the use of prescription NRTs (e.g. nicotine patches) has been extensively studied, little is known about how the public uses OTC NRTs in the real-world setting. To address this gap, we propose to perform the first exploratory U.S. consumer survey in an attempt to provide a "snapshot" of the ways in which the public is using OTC nicotine patches. SPECIFIC AIMS: 1) To describe the characteristics of the OTC nicotine patch consumers and their use patterns, and 2) To determine the factors associated with inappropriate use of OTC nicotine patches. METHODS: We propose to perform a cross-sectional survey of consumers (N=600) purchasing OTC nicotine patches in a stratified random sample of 30 retail pharmacies throughout Los Angeles County. In each pharmacy, participants will be recruited through shelf advertisements and will be asked to complete a self-administered, anonymous questionnaire containing these domains--demographics, smoking history, past medical history, other concurrent cessation methods, choice and previous use of NRT products, and factors influencing decision to purchase OTC nicotine patch. Explicit criteria for appropriateness of OTC nicotine use will be derived from medical literature and the indications and contraindications as per the package labels. SIGNIFICANCE: This study will 1) establish a novel community pharmacy-based data collection method, 2) raise physician awareness of how patients use OTC nicotine patches, and 3) provide the Food and Drug Administration (FDA) with post-marketing surveillance information regarding actual consumer usage patterns as compared to the intended use guidelines. This K23 Mentored Patient-Oriented Research Career Development Award will allow Dr. Shi to obtain a PhD in Health Services/Pharmaceutical Economics and Policy while performing an original mentored research project. These training experiences will help her consolidate the essential skills, knowledge, and collegial networks for establishing an academic health services research career and will further poise her expertise in topics and policies regarding over-the-counter medications.